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Histone Deacetylase (HDAC) Inhibitor and PI3K Inhibitor

CUDC-907 for Tumors

Phase 1
Waitlist Available
Led By David S Shulman, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age > 1 years and ≤ 21 years at time of enrollment
Karnofsky performance status ≥ 50% for patients ≥16 years of age and Lansky ≥ 50% for patients <16 years of age
Must not have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up2 years
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing a new drug to see if it can help kids with solid tumors, lymphoma, or brain tumors that haven't responded to other treatments.

Eligible Conditions
  • Lymphoma
  • Neuroblastoma
  • Brain Tumor
  • Solid Tumors

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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Participants must be between 1 and 21 years old when they join the study.
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You are able to perform daily activities at a certain level as determined by your doctor.
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Your disease must be able to be measured or evaluated.
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You have been diagnosed with solid tumors, brain tumors, or lymphoma based on a biopsy or surgery.
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You have a disease that has come back or is not responding to standard treatments.
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You must have a body size of at least 0.5 square meters.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Limiting Toxicity
Secondary outcome measures
Adverse Events per CTCAE Version 4
Duration of Response
Exposure (AUC) of CUDC-907 in Pediatrics
+3 more

Side effects data

From 2019 Phase 2 trial • 70 Patients • NCT02674750
72%
Diarrhea
54%
Hypokalemia
49%
Nausea
41%
Thrombocytopenia
40%
Hypomagnesia
35%
Fatigue
34%
Decreased appetite
28%
Vomiting
28%
Dehydration
26%
Anemia
26%
Dyspnea
21%
Constipation
21%
Arthralgia
21%
Neutropenia
19%
Pyrexia
19%
Pain in extremity
19%
Hyperuricemia
19%
Dizziness
18%
Abdominal Pain
18%
Hypocalcemia
16%
Back pain
16%
Acute Kidney Injury
13%
Cough
12%
Peripheral edema
10%
Diffuse Large B Cell lymphoma
9%
Upper Respiratory Infection
9%
Oropharyngeal Pain
9%
Musculoskeletal pain
9%
Headache
7%
Atrial fibrillation
7%
Asthensia
7%
Dysgeusia
7%
Pruritus
6%
Insomnia
6%
Dyspepsia
6%
Chills
6%
Sepsis
4%
Diarhhea
4%
Lymphoma
1%
Abdominal Pain Upper
1%
Asthenia
1%
Disease Progression
1%
Non-cardiac chest pain
1%
Cytomegalovirus
1%
Enterococcal
1%
Pneumonia
1%
Febrile Neutropenia
1%
Cholecystitis
1%
hyperbilirubenemia
1%
COPD
1%
Pulmonary Embolism
1%
Gullain-Barre Syndrome
1%
Device occulsion
1%
Small Intestinal Obstruction
1%
Citrobacter Batremia
1%
Wound infection
1%
Tracheal obstruction
100%
80%
60%
40%
20%
0%
Study treatment Arm
CUDC-907

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: CUDC-907Experimental Treatment1 Intervention
CUDC-907 orally administered CUDC-907 once daily for 5 consecutive days per week followed by two days without dosing Dose level assigned at registration Pre-dose pharmacokinetic blood sample will be collected Dose escalation will follow a standard 3+3 design
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CUDC-907
2016
Completed Phase 2
~120

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,058 Previous Clinical Trials
338,973 Total Patients Enrolled
59 Trials studying Lymphoma
2,385 Patients Enrolled for Lymphoma
Curis, Inc.Industry Sponsor
16 Previous Clinical Trials
1,088 Total Patients Enrolled
5 Trials studying Lymphoma
350 Patients Enrolled for Lymphoma
David S Shulman, MD5.01 ReviewsPrincipal Investigator - Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
2 Previous Clinical Trials
361 Total Patients Enrolled
1 Trials studying Lymphoma
21 Patients Enrolled for Lymphoma

Media Library

CUDC-907 (Histone Deacetylase (HDAC) Inhibitor and PI3K Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02909777 — Phase 1
Lymphoma Research Study Groups: CUDC-907
Lymphoma Clinical Trial 2023: CUDC-907 Highlights & Side Effects. Trial Name: NCT02909777 — Phase 1
CUDC-907 (Histone Deacetylase (HDAC) Inhibitor and PI3K Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02909777 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is geriatric participation being considered for this research project?

"As per the prerequisites for enrolment, this clinical trial has a lower age limit of 1 year old and an upper age cap of 21."

Answered by AI

Are there any vacancies remaining in this clinical trial?

"Affirmative. The details available on clinicaltrials.gov declare that this medical trial is currently recruiting participants, and the first posting was in October 1st 2016. 44 patients are needed from 4 different sites, with the information being most recently updated in August 13th 2022."

Answered by AI

How many healthcare facilities are administering this experiment?

"Several medical centres are accepting patients for this research trial, such as Dana Farber Cancer Institute in Boston, Children's Hospital of Philadelphia in Philadelphia, and University of Californiar Cancer Institute in Boston, Children's Hospital of Philadelphia in Philadelphia, and University of California at San Francisco Benioff Children's Hospital."

Answered by AI

Is this clinical investigation pioneering a new approach?

"Since its inception in 2016, CUDC-907 has been subject to a plethora of studies. Initially sponsored by Curis, Inc., the first trial involving 44 participants ultimately led to Phase 1 drug approval. Currently, two trials are ongoing over 19 cities and 2 countries."

Answered by AI

Has the FDA sanctioned CUDC-907 for commercial use?

"The safety of CUDC-907 was ranked a 1 due to the lack of data and clinical trials, signifying that it is in its initial stages."

Answered by AI

Could you outline the other investigations that have taken place with CUDC-907?

"Presently, there are two trials for CUDC-907 in progress; neither of which currently occupy Phase 3. Baltimore serves as the hub for many of these investigations, though 24 other locations scattered throughout the US also administer clinical tests with this medication."

Answered by AI

How many individuals have registered to be part of this research?

"In order to effectively conduct this trial, 44 eligible participants must be recruited. Curis, Inc., the sponsor of the study will manage it from locations such as Dana Farber Cancer Institute in Massachusetts and Children's Hospital of Philadelphia in Pennsylvaniaber Cancer Institute in Massachusetts and Children's Hospital of Philadelphia in Pennsylvania."

Answered by AI

Is my eligibility criteria sufficient to become involved in this research?

"This medical experiment is looking to enrol 44 individuals with lymphoma between 1 and 21 years of age. In order for a patient to be eligible, they must possess either histologically confirmed solid tumors, CNS tumours or lymphoma that can be identified through biopsy/surgery at initial diagnosis or relapse/progression; the only exception being pediatric patients diagnosed exclusively by imaging criteria (diffuse intrinsic pontine gliomas and optic pathway gliomas). Furthermore, participants must have measurable disease in both parts A and B that has relapsed/refractory responses towards standard treatments."

Answered by AI
~0 spots leftby Jan 2024